Human factors and IEC 62366 usability engineering for point-of-care diagnostics (IND-02)

We offer to lead or contribute to the human factors and usability engineering work in an IND-02 consortium.

The topic explicitly requires devices that are user-friendly and easy to use for specimen collection, based on a clinical needs assessment, with IVDR conformity assessment. Point-of-care tests are used by nurses, GPs, pharmacists and patients rather than lab staff, and many false results come from use errors in sample handling and result reading.

What we bring:

• User and context research as input to the clinical needs assessment and care pathway mapping, including resource-limited settings

• Use specification, user profiles and use-related risk analysis

• Iterative design and formative usability evaluation of the device, sample handling, smartphone readout, instructions for use and training

• Usability metrics for the comparative study (use errors, time to result, training time)

• Summative usability validation and the IEC 62366 usability engineering file for the IVDR technical documentation

What the consortium gains by working with us:

• A stronger proposal: the topic’s user-friendliness and ease-of-use criteria are covered by a dedicated partner with a clear method, which evaluators can score

• Fewer false results in the field: use errors in sample handling and result reading are identified and designed out before the clinical studies

• A smoother path to IVDR: usability evidence is built into the project from the start, ready for the technical documentation instead of patched together at the end

• Faster adoption: a device that nurses, GPs and patients can use with minimal training, which supports the HTA and value case

Possible role: work package lead for human factors and usability engineering, or task lead within the device optimisation or validation work package.

About us: Nordic Usability is a human factors and UX consultancy in Zürich, Switzerland, founded in 2009.